Sponsor study identifier
Secondary identifiers
REGISTRY · ANZCTR (Australian New Zealand Clinical Trials Registry
interventional
20
1 country
1
Study Start
November 13, 2019
Actual (reported)Primary Completion
November 11, 2020
Actual (reported)Study Completion
November 11, 2020
Actual (reported)Over 1 million patients globally currently manage their Type 1 Diabetes mellitus using continuous subcutaneous insulin infusion with an infusion set that needs to be changed every 3 days. This study will assess the feasibility and device performance of the study device, the Achilles infusion set over three periods during routine insulin infusion. This study will include 20 participants and has 3 periods: Period 1 (up to 7 days): Trial run with study device with saline infusion. Period 2 (up to 7 days): participants will manage their blood glucose solely with their insulin pump and the Achilles infusion set. Blood glucose will be closely monitored with a continuous glucose monitoring (CGM) device. Period 3 (up to 7 days): Participants will return to study center to receive a fresh Achilles infusion set and continue blood glucose management at home until infusion set failure or 7 days.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 11, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 13, 2019
Actual (reported)July 9, 2020
Actual (reported)August 7, 2020
Actual (reported)November 11, 2020
Actual (reported)November 11, 2020
Actual (reported)March 7, 2023
Actual (reported)Rate of Infusion Set Survival at End of Day 7
The composite primary objective of this study is to evaluate feasibility and device performance of the Achilles infusion set over three extended home use wear periods of up to 7 days each during routine therapeutic insulin infusion.
7 days during weeks 2 and 3
Coil-reinforced soft polymer indwelling cannula
This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Melbourne, Australia
David O'Neal, M.D.
St Vincent's Hospital Department of Medicine
20 participants (actual enrollment reported by the registry).
First Submitted
July 9, 2020
First Posted
August 7, 2020
Study Start
November 13, 2019
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 11, 2020
Actual (reported)Study Completion
November 11, 2020
Actual (reported)Last Updated
March 7, 2023
Results First Posted
March 7, 2023
Record last verified: 2022-05
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Source: ClinicalTrials.gov.
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